Artery medical apparatus and methods of use thereof

ABSTRACT

Methods and medical apparatus for deployment within an anatomical blood vessel. The medical apparatuses comprising: a first tubular wall, a second tubular wall, within the first tubular wall, and a constricting element configured to constrict a circumference of a portion of the second tubular wall; the combination of the first tubular wall, the second tubular wall and the constricting element forms a diametrical reducer.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/716,667 filed on Sep. 27, 2017, which claims the benefit of U.S.Provisional Patent Application No. 62/400,695 filed on Sep. 28, 2016.The contents of the above applications are all incorporated by referenceas if fully set forth herein in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The current invention relates to a medical device to be positionedwithin the main pulmonary artery and/or the pulmonary artery branches,and to methods of use thereof for treating, reducing the severity of, orreducing symptoms associated with, or any combination thereof,congestive heart failure, including left ventricular failure, whereinuse may in certain embodiments, affect the position and function of theinterventricular septum during systole.

Congestive heart failure (CHF) means the heart does not pump outsufficient blood to meet the body's demands. CHF can result from eithera reduced ability of the heart muscle to contract (systolic failure) orfrom a mechanical problem that limits the ability of the heart'schambers to fill with blood (diastolic failure). When weakened, theheart is unable to keep up with the demands placed upon it and the leftventricle (LV) gets backed up or congested. CHF is a progressivedisease. Failure of the left side of the heart (left-heartfailure/left-sided failure/left-ventricle failure) is the most commonform of the disease.

CHF affects people of all ages including children, but it occurs mostfrequently in those over age 60, and is the leading cause ofhospitalization and death in that age group. Current treatments of CHFinclude lifestyle changes, medications, and surgery to bypass blockedblood vessels, replace regurgitant or stenotic valves, install stents toopen narrowed coronary vessels, install pump assist devices ortransplantation of the heart.

Normal cardiac contraction is a finely tuned orchestrated activitydependent on muscle function, ventricular geometry and loadingconditions termed preload and afterload. When CHF due to LV systolicfailure occurs, it is typically associated with changes in the geometryof the ventricles, often called remodeling. The LV becomes dilated andthe interventricular septum is deflected into the right ventricle (RV),resulting in decreased LV output/pumping efficiency. The efficientsystolic function of the LV is dependent not only on the strength of themyocardium but also on the LV geometry, the position and shape of theinterventricular septum and the geometry and function of the RV.Interventricular dependence has been documented in experimental studieswhich have evaluated both normal and pathological preparations inanimals. LV systolic function can be directly influenced byinterventions affecting the RV and the position of the interventricularseptum.

Surgical pulmonary artery banding (PAB) is a technique that wasdescribed more than 60 years ago and is still in use today for childrenand infants with congenital heart defects, such as overflow of blood tothe lungs and volume overload of the RV. PAB is typically performedthrough a thoracotomy and involves wrapping a band around the exteriorof the main pulmonary artery (MPA) and fixing the band in place, oftenwith the use of sutures. Once applied, the band is tightened, narrowingthe diameter of the MPA, increasing resistance to flow, reducing bloodflow to the lungs, and reducing downstream pulmonary artery (PA)pressure.

Surgical PAB procedures involve the risks present with all surgicalprocedures. In addition, use of PAB has a number of particulardisadvantages and drawbacks. Primary among these drawbacks is theinability of the surgeon performing the procedure to accurately assess,from the hemodynamic standpoint, the optimal final diameter to which thePA should be adjusted. Often, the surgeon must rely upon his or herexperience in adjusting the band to achieve acceptable forward flowwhile decreasing the blood flow sufficiently to protect the pulmonaryvasculature.

It is also not uncommon for the band to migrate towards one of the mainpulmonary branches (usually the left), resulting in stenosis of theother main pulmonary branch (usually the right). There have also beenreports of hardening of the vessels around the band due to buildup ofcalcium deposits and scarring of the PA wall beneath the band, which canalso inhibit blood flow. Flow resistance due to PAB may change overtime, and additional surgeries to adjust band tightness occur in up toone third of patients. The band is typically removed in a subsequentoperation, for example, when a congenital malformation is corrected inthe child or infant.

In addition to the classical use of PAB for treatment of congenitaldefects in infants and children, there has been a recent report of useof surgical PAB for left ventricle dilated cardiomyopathy (LVDCM) ininfants and young children. This method includes increasing the pressureload on the right ventricle by placing a band around the pulmonaryartery. The increased pressure in the right ventricle caused a leftwardshift of the interventricular septum and improvement of left ventriclefunction. It was found that the optimal degree of constriction wasachieved when the RV pressure was approximately 60% to 70% of thesystemic level and so that the interventricular septum slightly moved toa midline position. The success of these procedures in infants andchildren has been reported to be possibly due to the potential formyocyte recovery and repopulation being significantly greater forinfants and young children than for adults. However, it is the positionof the inventors that the geometric improvements to the failing heartdue to PAB may be responsible, at least partially, for the observedimprovements in LV function, and therefore PAB for adult left ventricleheart failure may demonstrate similar improvement in LV function.

The MPA is not a favorable location for positioning an implant due toits relatively large diameter (˜30 mm) and short length (˜50 mm). Thefull length of the MPA is not usable for an implant due to the proximityto the pulmonary valve on one end, and the bifurcation to the pulmonarybranches on the other. It is estimated that the usable length of the MPAfor the implant is approximately 30 mm. Implantation of a short, widedevice into the MPA is very difficult, and there is significant dangerthat the device will rotate or otherwise not be placed concentric withthe MPA, in which case near complete blockage of the MPA could occur. Inaddition, the device may erroneously be placed either too close to thepulmonary valve or to the bifurcation.

It would be desirable to provide a relatively simple medical apparatuswhich could be implanted in a minimally-invasive fashion, and whichwould allow an adjustment of blood flow through a vessel. Gradualreduction in the diameter of the MPA may be desirable, but is notcurrently feasible with the surgical PAB approaches described above. Inaddition, it would be desirable to use the medical apparatus fortreatment of the mature adult population suffering from left ventricle(LV) failure.

The methods and apparatuses of this invention describe a medicalapparatus configured to reduce a diameter of a blood vessel for treatingor at least reducing the severity of a congestive failure of the heart,such as but not limited to: systolic heart failure, diastolic heartfailure, left ventricle (LV) heart failure, right ventricle (RV) heartfailure, congenital defects of the heart for which surgical pulmonaryartery banding (PAB) is used, and any other condition which requirespulmonary artery banding (PAB).

SUMMARY OF THE INVENTION

Some embodiments of the present invention provide a medical apparatusfor deployment within an anatomical blood vessel comprising:

-   -   a first tubular wall,    -   a second tubular wall, within the first tubular wall, and    -   a constricting element configured to constrict a circumference        of a portion of the second tubular wall;    -   the combination of the first tubular wall, the second tubular        wall and the constricting element forms a diametrical reducer.

In some embodiments, the first tubular wall is connected at least at oneend to the second tubular wall.

In some embodiments, at least a portion of the second tubular wall iscoated with a coating material.

In some embodiments, the first and second tubular walls are concentric.

In some embodiments, material of the first and second tubular wallscomprises at least one of the group consisting of: Nitinol, stainlesssteel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer,Platinum alloy and any combination thereof.

In some embodiments, the first tubular wall is made of a first materialand the second tubular wall is made of a second material.

In some embodiments, the first and second tubular walls are manufacturedby a process selected from: laser cutting, braiding, any combinationthereof.

In some embodiments, the ratio between the medical apparatus'slongitudinal length (L) and diameter of the first tubular wall (Dout) issmaller than 2.

In some embodiments, the constricting element comprises a loop section.

In some embodiments, the second tubular wall comprises at least onefixation element, configured to anchor the loop section and prevent itfrom longitudinal movement.

In some embodiments, the constriction element further comprises a tailsection configured to be pulled and/or pushed to adjust thecircumference of the loop section.

In some embodiments, the circumference of the loop section is locked atthe adjusted circumference

In some embodiments, the tail is configured to be detached afteradjustment of the loop section circumference.

In some embodiments, the tail section is configured to extend out of theblood vessel and into a subcutaneous space.

In some embodiments, the constricting element is configured forcircumference adjustment of the second tubular wall, while the medicalapparatus is within the anatomic vessel.

In some embodiments, the constriction provides the second tubular wallwith a radial neck section, configured for reduction of the effectivediameter of the anatomical blood vessel.

In some embodiments, the medical apparatus is collapsible and configuredto be delivered into the anatomic vessel via a catheter.

Some embodiments of the present invention provide a method for reductionof effective diameter of an anatomic vessel comprising:

-   -   providing a medical apparatus having a second tubular wall        deployed within a first tubular wall;    -   deploying the medical apparatus within an anatomical blood        vessel; and    -   constricting at least a portion of the second tubular wall,        thereby providing the second tubular wall with a radial neck        section.

In some embodiments, the step of constricting is configured for forminga diametrical reducer for the anatomical blood vessel.

In some embodiments, the step of providing further comprises providingthe medical apparatus with a constricting element configured for theconstricting of the portion of the second tubular wall.

In some embodiments, the constricting element comprises a loop sectionand a tail section.

In some embodiments, the step of constricting further comprisesadjusting the constriction, before, during, and/or after the step of thedeploying.

In some embodiments, the step of the deploying comprises delivering themedical apparatus into the anatomical blood vessel via a catheter.

In some embodiments, the method further comprises a step of expandingthe constricted portion of the second tubular wall, while within theanatomical blood vessel.

In some embodiments, the method further comprises a step of temporarilyor permanently locking the constricted section of the second tabularwall to a specific circumference.

In some embodiments, the method further comprises a step of detachingthe tail section from the constricting element.

In some embodiments, the method further comprises monitoring at leastone physiological parameter.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The subject matter regarded as the invention is particularly pointed outand distinctly claimed in the concluding portion of the specification.The invention, however, both as to organization and method of operation,together with objects, features, and advantages thereof, may beunderstood by reference to the following detailed description when readwith the accompanying drawings in which:

FIG. 1 conceptually depicts the medical apparatus, according to someembodiments of the invention, having an outer tubular wall, an innertubular wall, and a constricting element;

FIG. 2 conceptually depicts the medical apparatus, according to someembodiments of the invention, where a portion of the inner tubular wallis constricted;

FIG. 3 conceptually illustrates the medical apparatus, according to someembodiments of the invention, and its annotated dimensions;

FIGS. 4A and 4B conceptually illustrate and depict the formation of theinner tubular wall, according to some embodiments of the invention;

FIG. 5 conceptually depicts the medical apparatus, according to someembodiments of the invention, where the outer tubular wall ismanufactured by laser cut process, and the inner tubular wall ismanufactured by braiding process, the inner tubular wall is alsodemonstrated to have a coating material;

FIGS. 6A, 6B and 6C conceptually illustrate methods of use of themedical apparatus, according to some embodiments of the invention, whereFIG. 6A illustrates a step of providing, FIG. 6B illustrates a step ofdelivering and FIG. 6C illustrates a step of adjusting of theconstricting element;

FIG. 7 conceptually illustrates methods of use of the medical apparatus,according to some embodiments of the invention, optionally including astep of monitoring and/or a pulling mechanism for a step of adjusting;

FIGS. 8A and 8B conceptually illustrate methods of use of the medicalapparatus, according to some embodiments of the invention, including astep of expanding of the constricted section of the inner tubular wall(FIG. 8A), and after the expansion (FIG. 8B);

FIGS. 9A, 9B and 9C conceptually illustrate methods of use of themedical apparatus, according to some embodiments of the invention,including a step of delivering (FIG. 9A) the medical apparatus into ablood vessel, as one long tubular wall and a step of forming (FIGS. 9Band 9C) the inner tubular wall, by pushing the proximal end of the outertubular wall there-into, while the medical apparatus is deployed withinthe blood vessel;

FIG. 10 conceptually illustrates the medical apparatus, according tosome embodiments of the invention, where both the outer and the innertubular walls are manufactured by laser cut process;

FIG. 11 conceptually illustrates the medical apparatus, according tosome embodiments of the invention, where the constricting element isdeployed at the distal end of the inner tubular wall;

FIG. 12 conceptually illustrates the medical apparatus, according tosome embodiments of the invention, where the medical apparatus comprisesnon-concentric tubular walls;

FIG. 13 conceptually illustrates the medical apparatus, according tosome embodiments of the invention, where the constricting elementcomprises a wide band;

FIG. 14 conceptually illustrates the medical apparatus, according tosome embodiments of the invention, further comprising a lockingmechanism for the constricted section of the inner tubular wall;

FIGS. 15A and 15B conceptually illustrate the medical apparatus,according to some embodiments of the invention (front and side viewsrespectively), where the constriction element further comprises at leastone fixation element; and

FIG. 16 conceptually illustrates method of use steps for the medicalapparatus, according to some embodiments of the invention.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity. Further, where consideredappropriate, reference numerals may be repeated among the figures toindicate corresponding or analogous elements.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The following description is provided, alongside all chapters of thepresent invention, so that to enable any person skilled in the art tomake use of the invention and sets forth the best modes contemplated bythe inventor of carrying out this invention. Various modifications,however, will remain apparent to those skilled in the art, since thegeneric principles of the present invention have been definedspecifically to provide a medical apparatus configured to reduce adiameter of a blood vessel for treating or at least reducing theseverity of a congestive failure of the heart, such as but not limitedto: systolic heart failure, diastolic heart failure, left ventricle (LV)heart failure, right ventricle (RV) heart failure, congenital defects ofthe heart for which surgical pulmonary artery banding (PAB) is used, andany other condition which requires pulmonary artery banding (PAB).

As used herein, in one embodiment, the term “about”, refers to adeviance of between 0.0001-5% from the indicated number or range ofnumbers. In one embodiment, the term “about”, refers to a deviance ofbetween 1-10% from the indicated number or range of numbers. In oneembodiment, the term “about”, refers to a deviance of up to 25% from theindicated number or range of numbers.

According to some embodiments, the term “a” or “one” or “an” refers toat least one.

According to some embodiments the present invention provides astent-like medical apparatus, as demonstrated at least in FIG. 1 , whichis configured to reduce the effective diameter of an anatomical bloodvessel (150).

According to some embodiments, the medical apparatus (100) comprising:

-   -   an outer tubular wall (110),    -   an inner tubular wall (120) within the outer tubular wall, and    -   a constricting element (130) configured to tighten at least a        portion (121) of the inner tubular wall (120).

According to some embodiments, the combination of the outer tubular wall(110), the inner tubular wall (120) and the constricting element (130)forms a diametrical reducer, which is suitable to be implanted within ananatomical blood vessel (150).

According to some embodiments, the constriction (121) provides the innertubular wall (120) with a radial neck section (125). According to someembodiments, the neck section (125) is configured for reduction of theeffective diameter of an anatomical blood vessel (150). According tosome embodiments a gradual adjustment of the constricting element (130)can cause a gradual reduction of the effective diameter of theanatomical blood vessel.

According to some embodiments, the inner and outer tubular walls(110,120) are connected at their proximal ends (as demonstrated at leastin FIGS. 3, 10 and 11 ), at their distal ends (as demonstrated in FIGS.5 and 12 ) or at both ends (not shown). According to a preferredembodiment, the inner and outer tubular walls (110,120) are connected attheir proximal ends, configured for more stable blood flow within themedical apparatus (100).

According to some embodiments, in the case where the inner and outertubular walls are connect at only one end (distal or proximal), theconstriction or an adjustment of the constriction can cause a change inthe overall longitudinal length (L_(in)) of the inner tubular wall(120).

According to some embodiments, the medical apparatus further comprisesan arched section (140), for a non-limiting example a torus-like portion(as demonstrated at least in FIG. 2 ), configured to connect between theproximal ends and/or the distal ends of the inner and outer tubularwalls (110,120).

According to some embodiments, the outer and inner tubular walls(110,120) are concentric. According to some embodiments, the medicalapparatus is axisymmetric.

According to some embodiments, the material of the outer and innertubular walls comprises at least one from the group consisting of:Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalumalloy, polymer, Platinum alloy and any combination thereof.

According to some embodiments, the outer tubular wall is made of a firstmaterial and the inner tubular wall is made of a second material.According to some embodiments, the outer and inner tubular walls aremade of the same material.

According to some embodiments, at least a part of the inner tubular wallis coated (128), as demonstrated in FIG. 5 in order to cause the bloodflow in the blood vessel (150) to primarily flow through the innertubular wall (120). The coating material can be selected, for anon-limiting example, from: silicone elastomers, urethane containingpolymers (such as polyurethane, silicone-polyurethane, polycarbonateurethanes, and silicone polycarbonate urethanes), PTFE, PLA (includingPLGA, PLLA), xenograft or allograft tissue (such as pericardial tissue).

According to some embodiments, at least one of the outer and innertubular walls (110,120) is made of a collapsible memory shape material,therefore self-expanding material. According to some embodiments, atleast one of the outer and inner tubular walls (110,120) is manufacturedby laser cut process. According to some embodiments, at least one of theouter and inner tubular walls (110,120) is manufactured by braiding.According to a preferred embodiment the outer tubular wall (110) ismanufactured by a laser cut process and the inner tubular wall (120) ismanufactured by braiding (as shown in FIG. 5 ).

According to some embodiments, the ratio between the medical apparatus's(100) longitudinal length (L) and the diameter of the outer tubular wall(D_(out)) is smaller than a predetermined numeral (N=L/D_(out)) selectedfrom the group consisting of: 3, 2.5, 2, 1.5, 1, 0.5, 0.3 and any ratiowithin this range. According to a preferred embodiment, N is smallerthan 1.5. The dimension annotations for the medical apparatus can befound in FIG. 3 .

FIG. 3 demonstrates an example where the overall length of the apparatusL is determined by the length of the outer tubular wall (L=L_(out));alternately, FIG. 7 demonstrates an example where the overall length ofthe apparatus L is determined by the length of the inner tubular wall(L=L_(in)). FIG. 7 also demonstrates embodiments where the inner tubularwall extends out of the outer tubular wall (L_(in)>L_(out)) and where atleast a part of the protruding section (123) of the inner tubular wall(120) is in contact with the anatomical blood vessel (150).

According to some embodiments, the constricting element (130) comprisesa loop section (131), which can comprise one of: a ring, a band, a hoop,a noose, a hitch and any combination thereof.

According to some embodiments, the circumference of the loop section(131) is predetermined and fixed before delivery into the anatomicalblood vessel. According to some embodiments, the circumference of theloop section (131) can be adjusted. The circumference adjustment can beconducted prior to the insertion of the medical apparatus (100) into theanatomical blood vessel (150). For a non-limiting example, a physician's(or a care giver) prior to insertion adjustment is according to thepatient's clinical condition. Alternatively, the circumferenceadjustment can be conducted while the medical apparatus is within theblood vessel (150), e.g. during the implantation procedure and/or anytime after implantation. According to some embodiments the adjustmentcan be gradual, i.e., over hours, days or weeks after implantation.According to some embodiments, the adjustable loop section (131) can beonly tightened, and according to some embodiments it can be expandableas well, for a non-limiting example the adjustable loop section (131)can be expanded by an inflatable balloon (330), as demonstrated in FIG.8A, and after expansion in FIG. 8B.

According to some embodiments, the loop section (131) can be positionedat any location along the longitudinal axis X of the inner tubular wall(120). According to some embodiments, the loop section (131) is deployedat a predetermined location, prior to insertion of the medical apparatusto the blood vessel (150), as demonstrated in FIGS. 6A and 11 . FIG. 11demonstrates fixation of the loop section (131) at the distal end of theinner tubular wall (120), where the medical apparatus (100) is shownafter its implantation within the anatomical blood vessel.

According to some embodiments, the loop section (131) is fixated at aparticular location along the longitudinal axis X by at least partiallyweaving the loop section (131) through the struts of the outer tubularwall (110), as demonstrated in FIGS. 9C and 12 , thereby securing theloop section (131) in place.

According to some embodiments, the medical apparatus (100) iscollapsible and self-expanding and is configured to be delivered into ananatomical blood vessel (150) via a delivering system, e.g. a catheter(310), as demonstrated in FIG. 6B. In this example, the catheter's tipis marked by a large arrow (311) pointing to the direction of its'insertion; the withdrawal direction of the catheter's outer sheath(312), which releases the medical apparatus (100) into the anatomicalblood vessel (150), is marked by small arrows (313). According to someembodiments, the medical apparatus (100) can be provided to thephysician (or a care giver) together with the delivering catheter (310),where the medical apparatus (100) is already crimped there within, asshown in FIG. 6B.

According to some embodiments, the constricting element (130) furthercomprises a tail section (132) configured to be pulled (or pushed, ifthe tail section is non-flexible), in some embodiments, by a mechanismin the handle of the delivery system and thereby adjust thecircumference of the loop section (131) and accordingly the neck section(125) of the inner tubular wall.

According to some embodiments, the constricting element comprises anadjusting mechanism (320). In one embodiment, the adjusting mechanism(320) comprises a folded wire, where the folded section is passedthrough a tube element (321) and forms the loop section (136), whichextends out the distal end of the tube element (321), and where two tailsection/s (132) extend out of the proximal end of the tube element(321). In another embodiment the adjusting mechanism (320) comprises alooped wire with a sliding knot (hence the loop section), with thesingle wire passed through a tube element (321) and extending out of itsdistal end, and where the wire's single tail (hence tail section),extends out of the tube element's (321) proximal end. According to bothadjusting mechanism (320) examples, by pulling the wire's tail section/s(132), while holding the tube element (321) stationary, the wire's loopsection (136) is tightened and thereby its circumference is reduced.

According to some embodiment, the proximal end of the adjustingmechanism (320) can be extended out of the blood vessel and into asubcutaneous space, which can provide access for post procedureadjustment (e.g. post implantation adjustment). More specifically, thewire's tail section/s (132) together with the proximal end of the tubeelement (321) can be extended out of the blood vessel and into asubcutaneous space.

According to some embodiments, the tail section (132) extends out of theblood vessel, for a non-limiting example, through the right side of theheart and to a subcutaneous space. According to some embodiments, anactuator (350) can further pull and/or push the proximal end of the tailsection (132) for adjustment of the circumference of the loop section(131) of the constricting element (130), as demonstrated in FIG. 7 .

According to some embodiments, the loop section (131), after itscircumference adjustment, can be temporarily or permanently fixed orlocked to the selected circumference, and according to some embodiments,the tail section (132) can be detached (133) from the loop section(131), for a non-limiting example, at a point near the medicalapparatus, as demonstrated in FIG. 6C.

According to some embodiments, the medical apparatus (100) is deliveredas a single tubular wall (115) where the inner tubular (120) wall isformed by radially folding at least one end (distal and/or proximal end)of the single tubular wall (115) there-into and into the loop section(130), and thereby to form the inner tubular wall (120) with a diameterD_(in)<D_(out). According to some embodiments, the folding and formingof the inner tubular wall (120) can be conducted at a prior stage, e.g.at the manufacturing stage, as demonstrated in FIGS. 4A and 4B, or whilewithin the anatomical blood vessel (150), as demonstrated in FIGS.9A-9C.

According to some embodiments the present invention provides a method(200) for reducing the effective diameter of an anatomic vessel (150).The method (200) comprising steps of:

-   -   providing (210) a medical apparatus (100) having an inner        tubular wall (120) within an outer tubular wall (110);    -   deploying (220) the medical apparatus within an anatomical blood        vessel; and    -   constricting (230) at least a portion (121) of the inner tubular        wall (120), thereby providing the inner tubular wall (120) with        a radial neck section (125).

According to some embodiments, the step of constricting (230) isconfigured for forming a diametrical reducer for the anatomical bloodvessel (150). According to some embodiments, the constricting isgradual, by means of step wise constriction over a predetermined periodof time, for a non-limiting example, every couple of days or weeks;which can lead to a gradual and controlled reduction of the effectivediameter of the anatomical blood vessel.

According to some embodiments, the step of providing (210) furthercomprises providing (211) the medical apparatus with a constrictingelement (130) configured for the constricting of the portion (121) ofthe inner tubular wall (120). According to some embodiments, theconstricting element (130) comprises a loop section (131) and canfurther comprise a tail section (132), as detailed above.

According to some embodiments, the step of constricting (230) furthercomprises adjusting (231) the constriction. Adjusting the constrictioncan be at any time of the treatment procedure, i.e. before deployment ofthe medical apparatus (as in FIG. 6A), during the deployment (while atleast part of the delivery system is in the anatomical vessel), andafter the step of the deploying (220); according to the latter (afterthe deployment), the step of adjusting (231) is conducted while themedical apparatus is within the anatomical vessel (150), as demonstratedin FIGS. 6C, 7 and 10 .

According to some embodiments, the adjusting can be gradual, for gradualand controlled adjustment of the effective diameter of the anatomicalblood vessel.

According to some embodiments, the step of deploying (220) comprisesdelivering (221) the medical apparatus by a trans-catheter procedureinto the anatomical blood vessel (150) via a catheter (310), asdemonstrated in FIGS. 6B and 9A.

According to some embodiments, the method (200) further comprises a stepof expanding (240) the constricted portion of the inner tubular wall,while within the anatomical blood vessel (150), for a non-limitingexample: by an inflatable balloon (330), delivered and controlled by acatheter (331), as demonstrated in FIG. 8A, or according to anothernon-limiting example by the adjusting mechanism (320), as described inFIGS. 6C and 12 , in the case where the wire is non-flexible. Accordingto some embodiments, the expanding takes place either at the end of thetreatment, in which the constriction is expanded to terminate thetherapy, or during the deployment process, where the expanding may berequired in the case where the medical apparatus has been constrictedtoo tightly, and needs to be expanded and retightened again. Accordingto some embodiments the expanding can be gradual.

According to some embodiments, the method (200) further comprises a stepof temporarily or permanently locking (250) the constricted section ofthe inner tabular wall (120) to a specific circumference. According tosome embodiments, the locking can be performed by using a lockingmechanism (372) for the constricted area of the inner tubular wall(120), for a non-limiting example as demonstrated in FIG. 14 .

According to some embodiments, the method (200) further comprises a stepof detaching (260) the tail section (132) of the constricting element(130), according to some embodiments after the step of locking (250), asdemonstrated in FIG. 6C (133). The tail section (132) can then beretracted out of the anatomical blood vessel and patient's body togetherwith the delivery system.

According to some embodiments, in the case where the medical apparatus(100) is delivered as a single tubular wall (115), the providing (210)comprises forming (212) the inner tubular wall (120) by pushing in atleast one end-portion (111) of the single tubular wall (115) andradially folding thereof into. According to some embodiments, the stepof forming (212) can be performed before the step of deploying (220) themedical apparatus; according to other embodiments the step of forming(212) can be performed after the step of deploying (220), while themedical apparatus (100) is within the anatomical blood vessel (150), byusing a catheter (360). According to a preferred embodiment, the forming(212), before or while the medical apparatus is within the blood vessel,can be achieved when at least part of the single tubular wall (115) ismanufactured by a braiding process.

According to some embodiments, the method (200) further comprisesmonitoring (270) at least one physiological parameter, in order examinethe effects of treatment by use of the medical apparatus. According tosome embodiments, the monitoring (270) is performed during at least oneof the steps of: deploying (220), delivering (221), forming (212),constricting (230), adjusting (231), expanding (240), locking (250) anddetaching (260). According to a preferred embodiment, the monitoring(270) is configured for the adjusting (231) of the constriction of theinner tubular wall (120). According to some embodiments, the at leastone monitored physiological parameter can be compared to a baselinereading of the same (e.g. prior to treatment), in order examine theeffects of treatment.

According to some embodiments, monitoring (270), comprises at least oneof:

-   -   measuring blood pressure; for non-limiting examples: measuring        the right ventricle (RV) systolic pressure, measuring the left        ventricle (LV) systolic pressure; measuring the RV diastolic        pressure; measuring the LV diastolic pressure; measuring the        pressure gradient across the vessel constriction;    -   imaging the constricted anatomical blood vessel and/or it's        adjacent blood vessel/s, and measuring degree of the vessel/s's        constriction; and    -   measuring heart rate;    -   any combination thereof.

According to some embodiments, a therapeutic result for the use of themedical apparatus (100) can be at least one of the group consisting of:

-   -   an increase in the left ventricle ejection fraction (LVEF);    -   a decrease in the left ventricle end diastolic pressure (LVEDP);    -   improvement in the clinical symptoms of heart failure; and    -   any combination thereof.

Reference is now made to FIGS. 1 and 2 (side views), which conceptuallydepict the medical apparatus (100), according to some embodiments of theinvention, having an outer tubular wall (110), an inner tubular wall(120), and a constricting element (130) comprised of a loop section(131) and a tail section (132). The constricting element (130) isconfigured to constrict a circumference (121) of a portion of the innertubular wall (120) and provide the inner tubular wall with a radial necksection (125), as shown in FIGS. 1 and 2 , before and after constriction(respectively).

Reference is now made to FIG. 3 (side cross-sectional view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, and its annotated dimensions. FIG. 3shows: the medical apparatus's longitudinal axis X, radial axis r andangular axis θ, according to a cylindrical coordinate system; the outerdiameter of the medical apparatus (100), which is actually the diameterof the outer tubular wall D_(out), the diameter at the narrowest sectionof the inner tubular wall D_(neck); the longitudinal length of the innertubular wall L_(in); and the total length of the medical apparatus L,which in this case is the length of the outer tubular wall.

Reference is now made to FIGS. 4A and 4B (side cross-sectional view andfront view, respectively), which conceptually illustrate and depict theformation of the inner tubular wall, according to some embodiments ofthe invention. According to some embodiments, the medical apparatus(100) is manufactured as a single tubular wall (115). The inner tubular(120) wall is formed by radially folding at least one end (distal and/orproximal) of the single tubular wall (115) there-into and according tosome embodiments also into the loop section, and thereby forming theinner tubular wall (120) with a diameter D_(in)<D_(out).

FIGS. 4A and 4B demonstrate the folding and forming of the inner tubularwall (120) conducted at a prior stage, e.g. at the manufacturing stage.FIG. 4A demonstrates a longitudinal view at the beginning of the foldingprocess, while FIG. 4B depicts a frontal view, demonstrating the foldedarched section (140). FIGS. 9A-9C demonstrate the folding and forming ofthe inner tubular wall (120) conducted while the medical apparatus iswithin the anatomical blood vessel (150).

According to a preferred embodiment, the forming, before or while themedical apparatus is within the blood vessel, can be achieved when atleast part of the single tubular wall (115) is manufactured by abraiding process.

Reference is now made to FIG. 5 (side view), which conceptually depictsthe medical apparatus (100), according to some embodiments of theinvention, where the outer tubular wall (110) is manufactured by lasercut process (119), and the inner tubular wall (120) is manufactured bybraiding process (129). FIG. 5 further demonstrates the inner tubularwall (120) coated with a coating material (128) configured to cause theblood flowing through the blood vessel to primarily flow through theconstricted section of the inner tubular wall. FIG. 5 furtherdemonstrates that the inner and outer tubular walls (110,120) areconnected at their distal end (127) by suture connection or by any othermeans known in the art.

Reference is now made to FIGS. 6A, 6B and 6C (side cross section views),which conceptually illustrate methods of use of the medical apparatus,according to some embodiments of the invention. FIG. 6A illustrates astep of providing of the medical apparatus, where the circumference ofthe constricting element (130) is set or adjusted at a prior stage, e.g.at the time of manufacture and/or before the deployment of the medicalapparatus (100) within the blood vessel.

FIG. 6B illustrates a step of delivering into the blood vessel, wherethe medical apparatus is in a collapsed configuration, being deliveredbe a catheter (310). The catheter's tip is marked by a large arrow (311)which points to the direction of its' insertion, and the small arrowspoint to the withdrawal direction of the catheter's sheath (312), whichreleases the medical apparatus (100) into the anatomical blood vessel(150).

FIG. 6C illustrates a step of adjusting of the constricting element(130). According to some embodiments the at least a portion (121) of theinner tubular wall (120) is tightened and adjusted by an adjustingmechanism (320). According to some embodiments the adjusting mechanism(320) comprises a folded wire which is at least partially passed througha tube element (321). The wire is therefore configured to have the loopsection (136) which extends out the distal end of tube element (321) andtwo tail wires, as the tail section (132), which extend out of theproximal end of the tube element (321). According to some embodiments,the adjusting mechanism (320) comprises a looped wire with a slidingknot with the single wire passed through a tube element (321). The wireis therefore configured to have the loop section (136) which extends outthe distal end of tube element (321) and the tail section (132) whichextends out of the proximal end of the tube element (321).

A counter-force holding the tube element (321) stationary, while thewire tail/s (132) is/are pulled or pushed, can tighten or expand thecircumference of the wire loop section (136), respectively.

According to some embodiments, the tube element and the wire tailsection extend out of the blood vessels and to a subcutaneous space foraccess for later adjustment. According to other embodiments the tube andthe wire tail are connected to, and operated by, the delivery system.

FIG. 6C further demonstrates the optional step of detaching (260) atleast a part of the tail section from the constricting element (133);the tail section (132) can then be retracted out of the anatomical bloodvessel and out of the patient's body.

Reference is now made to FIG. 7 (side cross section view), whichconceptually illustrates methods of use of the medical apparatus,according to some embodiments of the invention. FIG. 7 demonstrates thestep of monitoring (260), as mentioned above, optionally using amonitoring device (340) for displaying the monitoring features. FIG. 7further demonstrates an actuator or a pulling mechanism (350) connectedto the tail section (132) of the constricting element (130), configuredfor the step of adjusting (231), where the tail section (132) is pulledby a mechanism in the handle (not shown) of the delivery system, orwhere the tail section extends out of the blood vessel and to a positionin the subcutaneous space, where it can be later used to adjust thelevel of constriction.

Reference is now made to FIGS. 8A and 8B (side cross section views),which conceptually illustrate methods use of the medical apparatus,according to some embodiments of the invention. FIG. 8A demonstrates thestep of expanding (240) of the constricted section together with theloop section (131), using an inflatable balloon (330) being deliveredand controlled be a catheter (331). FIG. 8B demonstrates the constrictedsection after the expansion. As mentioned above, the steps of adjusting,expanding and detaching can be monitored and displayed by the monitoringdevice (340).

Reference is now made to FIGS. 9A, 9B and 9C (side cross section views),which conceptually illustrate the formation of the inner tubular wall(120), while the medical apparatus is within the anatomical blood vessel(150), according to some embodiments of the invention. FIG. 9Ademonstrates the step of delivering the medical apparatus into a bloodvessel (150), as a collapsed long single tubular wall (115), deliveredby catheter (310).

FIGS. 9B and 9C demonstrate the step of forming (212) the inner tubularwall (120), by pushing the proximal end (111) of the long tubular wall(115) and radially folding it there-into. According to a non-limitingexample of FIG. 9B, the loop section (131) can be pre-positioned withinthe single tubular wall (115) close to the inner circumference of whatwill later be the outer tubular wall (but not attached to it), and afterthe folding step, the loop section (131) is positioned between the outer(110) and the inner (120) tubular walls.

According to a non-limiting example of FIG. 9C, the loop section (131)can be initially attached (for example braided) to the single tubularwall (115) along the outer circumference of what will later be the innertubular wall, and then be radially folded together with the proximal end(111); therefore after the folding step, the loop section (131) remainsalong the outer circumference of the newly formed inner tubular wall(120).

The forming is conducted by the delivery system (310) having a tubularpushing tube (360).

Reference is now made to FIG. 10 (side cross section view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, where both the outer (110) and the inner(120) tubular walls are manufactured by laser cut process, and thereforeboth are configured with a firm construction.

Reference is now made to FIG. 11 (side cross section view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, where the constricting element (130) ispositioned at the distal end of the inner tubular wall, and therebyproviding the medical apparatus with a nozzle configuration.

Reference is now made to FIG. 12 (side cross section view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, where the medical apparatus (100)comprises non-concentric tubular walls (110,122). FIG. 12 describes anon-limiting example where the loop section (131) is connected oranchored to the inner surface of the outer tubular wall (110) at leastat one circumferential location (117) which anchors the loop section(131) and prevents it from moving in a longitudinal direction, ordislodging from the medical apparatus. According to the presentedexample of FIG. 12 , the anchored loop section (131) is furtherprevented from radial migration of the connection location (117), andtherefore the constricted inner tubular wall (120) is pulled towards theanchoring location (117). By pulling on the tail section (132), the loopsection (131) tightens the inner tubular wall (122) into a constricteddiameter that is not concentric with the outer tubular wall (110). FIG.12 further demonstrates the configuration of the constricting elementconfigured as the adjusting mechanism (320) having a wire and a tubeelement.

Reference is now made to FIG. 13 (side cross section view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, where the constricting element comprises awide band (371), configured for a longer section of constricteddiameter, which in some embodiments provides a more stable flow patternand/or a more pronounce pressure differential across the medicalapparatus during blood flow.

Reference is now made to FIG. 14 (side cross section view), whichconceptually illustrates the medical apparatus, according to someembodiments of the invention, further comprising a locking mechanism(372) for the constricted section of the inner tubular wall (120).According to some embodiment, the locking mechanism (372) comprises aband with ratchet pins (373) and a screw connection (374), such that theband can be can be tightened by tightening the screw connection, andremain fixed at the set tightened position. According to someembodiments the screw is operated by a mechanism in the delivery system.

Reference is now made to FIGS. 15A and 15B (side cross section view andfront cross section view, respectively), which conceptually illustratethe medical apparatus, according to some embodiments of the invention,where the constriction element (130) further comprises at least onefixation element (135), which in this example is located on the exteriorcircumference of the inner tubular wall. The at least one fixationelement (135) is configured to specifically position the loop section(131) of the constriction element and prevent it from longitudinalmovement, while allowing its degree of constriction to be adjusted.According so some embodiments, the fixation element/s (135) comprise atleast one of: a ring, a band, a suture, a hook, a hoop, a noose, a hitchand any combination thereof.

Reference is now made to FIG. 16 , which conceptually illustratesoptional method of use steps for the medical apparatus, according tosome embodiments of the invention. FIG. 16 shows the method steps in amap-like configuration, to conceptually demonstrate the optional methodpaths.

While certain features of the invention have been illustrated anddescribed herein, many modifications, substitutions, changes, andequivalents will now occur to those of ordinary skill in the art. It is,therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the invention.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting. In addition, any priority document(s) of this applicationis/are hereby incorporated herein by reference in its/their entirety.

What is claimed is:
 1. A method for treating an adult patient, themethod comprising: selecting an adult patient with a therapeutic goal ofdecreasing left ventricle end diastolic pressure; implanting a medicaldevice in a pulmonary artery of the patient; reducing an effectivediameter of a portion of the pulmonary artery with the medical device byadjusting an inner diameter of the medical device; and affecting thedecrease in left ventricle end diastolic pressure based on the reducing.2. The method of claim 1, wherein the selecting further comprisesselecting an adult patient with heart failure.
 3. The method of claim 1,wherein the selecting further comprises selecting an adult patient withcongestive heart failure.
 4. The method of claim 1, wherein the medicaldevice is implanted in the main pulmonary artery.
 5. The method of claim1, wherein the medical device is implanted in a pulmonary artery branch.6. The method of claim 1, further comprising adjusting the effectivediameter after the implanting, by further reducing the effectivediameter.
 7. The method of claim 6, wherein the reduction of theeffective diameter is performed gradually over hours, days or weeksafter the implanting.
 8. The method of claim 6, wherein the adjustingincludes expanding the effective diameter provided by the medicaldevice, in the case where the medical device has been constricted tootightly, and needs to be expanded.
 9. The method of claim 1, furthercomprising imaging the portion of the pulmonary artery and measuring theeffective diameter.
 10. The method of claim 1, further comprisingmonitoring one or more of the right ventricle (RV) systolic pressure,the left ventricle (LV) systolic pressure, the RV diastolic pressure,and the LV diastolic pressure and adjusting the effective diameter basedon the monitoring.
 11. The method of claim 1, comprising detecting apressure gradient across the portion of the pulmonary artery with thereduced effective diameter and adjusting the effective diameter based onthe detecting.
 12. The method of claim 1, wherein adjusting the innerdiameter of the medical device is performed before the implanting orafter the implanting.
 13. The method of claim 1, wherein the medicaldevice includes an inner tubular wall deployed within an outer tubularwall and wherein reducing the effective diameter is based onconstricting a diameter of the inner tubular wall.
 14. The method ofclaim 13, forming a radial neck section in the inner tubular wall basedon the constricting.
 15. The method of claim 1, wherein the medicaldevice includes a constricting element configured to constrict an innerdiameter of the medical device, the constricting element comprising: aloop section, a tail section configured to be pulled and/or pushed toadjust the circumference of the loop section; and a locking mechanismconfigured to lock the circumference of the loop section at the adjustedcircumference.
 16. The method of claim 15 further comprising detachingthe tail section after adjustment of the loop section circumference. 17.The method of claim 1, comprising delivering the medical device to thepulmonary artery with a catheter.
 18. The method of claim 1, furthercomprising affecting a position of the interventricular septum duringsystole with the medical device based on the reducing.
 19. The method ofclaim 1, wherein reducing the effective diameter is configured toincrease left ventricle ejection fraction.
 20. The method of claim 1,wherein the decrease in left ventricle end diastolic pressure isconfigured to reduce symptoms associated with one or more of systolicheart failure, diastolic heart failure, left ventricle (LV) heartfailure and right ventricle (RV) heart failure.
 21. The method of claim1, comprising adjusting the effective diameter after the implanting, byaccessing a subcutaneous space and operating a part of the medicaldevice that extends out of the blood vessel into said subcutaneousspace.
 22. The method of claim 1, wherein said selecting an adultpatient comprises selecting an adult patient with an additionaltherapeutic goal of increasing the left ventricle ejection fraction. 23.The method of claim 1, comprising adjusting the effective diameter afterthe implanting, by further reducing the effective diameter, in steps.24. The method of claim 1, comprising adjusting the effective diameterpre-insertion, according to the patient's clinical condition.
 25. Themethod of claim 8, wherein the expanding further comprises retighteningof the medical device.